Trial Outcomes & Findings for Effects of Human Leptin Replacement (NCT NCT00657605)
NCT ID: NCT00657605
Last Updated: 2020-02-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
Baseline, 107 months
Results posted on
2020-02-13
Participant Flow
Participant milestones
| Measure |
Recombinant Methionyl Human Leptin
Participants with congenital leptin deficiency will receive the Recombinant methionyl human leptin intervention subcutaneously, once a day with a dose of 0.02 to 0.04 mg/kg (adjusted according to weight loss).
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Human Leptin Replacement
Baseline characteristics by cohort
| Measure |
Recombinant Methionyl Human Leptin
n=3 Participants
Participants with congenital leptin deficiency will receive the Recombinant methionyl human leptin intervention subcutaneously, once a day with a dose of 0.02 to 0.04 mg/kg (adjusted according to weight loss).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, 107 monthsOutcome measures
| Measure |
Recombinant Methionyl Human Leptin
n=3 Participants
Participants with congenital leptin deficiency will receive the Recombinant methionyl human leptin intervention subcutaneously, once a day with a dose of 0.02 to 0.04 mg/kg (adjusted according to weight loss).
|
|---|---|
|
Change in Weight
|
NA lbs
Results not reported due to participant confidentiality.
|
SECONDARY outcome
Timeframe: Baseline, 107 monthsOutcome measures
| Measure |
Recombinant Methionyl Human Leptin
n=3 Participants
Participants with congenital leptin deficiency will receive the Recombinant methionyl human leptin intervention subcutaneously, once a day with a dose of 0.02 to 0.04 mg/kg (adjusted according to weight loss).
|
|---|---|
|
Change in Glucose Levels
|
NA mg/dL
Results not reported due to participant confidentiality.
|
Adverse Events
Recombinant Methionyl Human Leptin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place